Post Approval Study of the CyPass System



Status:Active, not recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:45 - Any
Updated:2/6/2019
Start Date:October 12, 2017
End Date:October 2021

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Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery

The purpose of this study is to demonstrate that the rate of clinically relevant
complications associated with CyPass Micro-Stent placement and stability using the CyPass
241-S applier, as determined at 36 months in the postmarket setting, is less than the
pre-specified performance target, which is based on experience with the CyPass Model E
applier in the COMPASS (TMI-09-01) Trial.

Each subject's expected participation in the study is up to 37.5 months which includes up to
42 days between the screening and surgery visits, and 36 months of post-surgery follow-up.
Only one eye per subject will be implanted.

Inclusion Criteria:

- Able to understand the requirements of the study and willing to follow study
instructions, provide written informed consent, and agree to comply with all study
requirements, including the required study follow-up visits

- Diagnosis of primary open angle glaucoma (POAG)

- Medicated IOP of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of
≥21 mmHg and ≤33 mmHg

- An operable age-related cataract eligible for phacoemulsification

- Visual acuity as specified in the protocol

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Inability to complete a visual field test prior to surgery

- Use of ocular hypotensive medication/s, as specified in the protocol

- Diagnosis of glaucoma other than POAG, as specified in the protocol

- Other medical conditions, as specified in the protocol

- Proliferative diabetic retinopathy

- Previous surgery for retinal detachment

- Previous corneal surgery

- Wet age-related macular degeneration

- Poor vision in the non-study eye not due to cataract

- Significant ocular inflammation or infection within 30 days of screening visit

- Uncontrolled systemic diseases that may put the subject's health at risk and/or
prevent the subject from completing all study visits

- Women who are pregnant or nursing

- Other protocol-specified exclusion criteria may apply.
We found this trial at
22
sites
Saint Louis, Missouri 63131
1573
mi
from 91732
Saint Louis, MO
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Austin, Texas 78731
?
mi
from 91732
Austin, TX
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Bala-Cynwyd, Pennsylvania 19004
2371
mi
from 91732
Bala-Cynwyd, PA
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Bellevue, Washington 98004
?
mi
from 91732
Bellevue, WA
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Chambersburg, Pennsylvania 17201
?
mi
from 91732
Chambersburg, PA
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El Paso, Texas 79902
?
mi
from 91732
El Paso, TX
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Fort Collins, Colorado 80525
839
mi
from 91732
Fort Collins, CO
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Fraser, Michigan 48026
1973
mi
from 91732
Fraser, MI
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Gainesville, Georgia 30501
1944
mi
from 91732
Gainesville, GA
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Garden City, Kansas 67846
993
mi
from 91732
Garden City, KS
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Houston, Texas 77204
1358
mi
from 91732
Houston, TX
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16691 Gothard Street
Huntington Beach, California 92647
24
mi
from 91732
Huntington Beach, CA
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Jacksonville, Florida 32256
2130
mi
from 91732
Jacksonville, FL
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Kenosha, Wisconsin 53142
?
mi
from 91732
Kenosha, WI
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Marietta, Georgia 30060
1908
mi
from 91732
Marietta, GA
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Mount Dora, Florida 32757
2163
mi
from 91732
Mount Dora, FL
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Orange, California 92868
21
mi
from 91732
Orange, CA
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Panama City, Florida 32405
1904
mi
from 91732
Panama City, FL
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Phoenix, Arizona 85032
343
mi
from 91732
Phoenix, AZ
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Racine, Wisconsin 53405
?
mi
from 91732
Racine, WI
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Saint Louis, Missouri 63131
?
mi
from 91732
Saint Louis, MO
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Vineland, New Jersey 08361
2385
mi
from 91732
Vineland, NJ
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